Moderate Anxiety Perimenopause Psychological Stress Sleep Quality Synbiotics Anxiety Perimenopause Psychobiotics Middle Aged Women Gut Brain Axis
Conditions
Interventions
MOOD PRO MS Dietary Supplement Product JHAMJUN Brand Powder form 2g sachet containing Probiotics Lactobacillus helveticus and Bifidobacterium longum Prebiotic GOS and synergistic nutrients Vit B compl
MOOD PRO MS,Placebo
Sponsors
Dhurakij Pundit University
Eligibility
Sex/Gender
Female
Age
40 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Thai female, aged 40-50 years. 2. In perimenopausal stage (early or late transition). 3. Having moderate anxiety (GAD-7 score of 10-14). 4. Voluntary participation and signed informed consent. 5. Able to comply with study procedures for 4 weeks. 6. Able to access and use the internet for online assessments.
Exclusion criteria
Exclusion criteria: 1. History of hysterectomy and/or bilateral oophorectomy. 2. Pregnant or breastfeeding. 3. Currently receiving hormone replacement therapy (HRT) or hormonal contraceptives. 4. Currently using antidepressants, anxiolytics, hypnotics, or other psychiatric medications. 5. Use of antibiotics within 1 month prior to screening. 6. Regular consumption of probiotic or synbiotic products within 1 month prior to screening. 7. Diagnosis of severe psychiatric disorders (e.g., major depression, bipolar disorder, suicide risk). 8. Alcohol or substance abuse. 9. Uncontrolled chronic diseases, autoimmune diseases, or severe gastrointestinal diseases. 10. History of allergy to lactic acid bacteria. 11. BMI less than 18.5 or greater than 30.0 kg/m2. 12. Current smoker or consumes alcohol > 3 times/week. 13. Shift worker affecting sleep patterns.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Anxiety Level Baseline and Week 4 Generalized Anxiety Disorder-7 (GAD-7) scale score. | — |
Secondary
| Measure | Time frame |
|---|---|
| Stress Level Baseline and Week 4 Perceived Stress Scale-10 (PSS-10) score.,Sleep Quality Baseline and Week 4 Pittsburgh Sleep Quality Index (PSQI) score.,Safety and Tolerability Throughout the 4-week study period Incidence and severity of adverse events (AEs), especially gastrointestinal symptoms.,Change in Dietary Patterns Baseline and Week 4 Food Frequency Questionnaire (FFQ) score.,Change in Physical Activity Level Baseline and Week 4 International Physical Activity Questionnaire (IPAQ) score. | — |
Countries
Thailand
Contacts
Public ContactParichat Wongpuk
Dhurakij Pundit University
Outcome results
None listed